Considering alloHCT: Opportunities for Patient Reflection During Decision-Making Via Digital Stories

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Rochester

About this trial

This is a two-arm pilot randomized trial that assesses the feasibility and preliminary efficacy of a digital story and values clarification intervention (Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories \[CHORDS\]) compared to usual care among patients with myeloid cancers considering allogeneic hematopoietic cell transplantation (alloHCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >21 years old

Diagnosis of myeloid cancer (e.g. AML, MDS, myelofibrosis, CML, or MDS/MPN)

Being considered for alloHCT

Able to provide informed consent

Disqualifiers

Age >18 years old

Selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters."

Caregiver may be paid/professional or informal caregiver

Able to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHORDS

    Other intervention

    The CHORDS intervention consists of 1) digital stories created by individuals who previously underwent consultation for alloHCT and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling (BWS).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention (CHORDS)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Retained (Feasibility - Retention Rate)

Feasibility will be assessed based on the percentage of enrolled participants who complete both the intervention and post-intervention secondary outcome assessments. The number of participants who complete all study procedures will be divided by the total number enrolled to calculate the retention rate. Higher percentages indicate greater feasibility.

Time frame
From enrollment (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

Secondary outcomes

1

Mean Change in Decisional Engagement Scale Score

Engagement in decision making will be assessed using the Decisional Engagement Scale, a self-reported measure evaluating patient involvement and perceived shared decision making. A single score will be derived according to scale instructions. Higher scores indicate greater engagement in decision making. There are 10 items in the scale, with each items score ranging from 0 to 10 (range 0-100 for the entire scale).

Time frame
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
2

Mean Change in Decisional Conflict Scale Score

Decisional conflict will be assessed using the Decisional Conflict Scale, a validated self-report instrument that measures personal uncertainty in making health-related decisions. The total score is derived by averaging item responses according to the scoring manual (range 0-100). Higher scores indicate greater decisional conflict (worse outcome), while lower scores indicate less conflict (improvement).

Time frame
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
3

Mean Change in Distress Thermometer Score

Psychological distress will be measured using the NCCN Distress Thermometer, a single-item visual analog scale ranging from 0 ("no distress") to 10 ("extreme distress"). Higher scores indicate greater distress.

Time frame
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

Other outcomes

1

Qualitative Analysis of Patient-Hematologist Discussion of Values and Goals

Audio recordings of alloHCT office visits will be transcribed and analyzed using qualitative methods to identify the presence and nature of discussions related to patient values and treatment goals.

Time frame
Following alloHCT office visit (Day 9 to 194)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.